Inhalation mask induction is the standard method for inducing anesthesia in pediatric patients. In the preoperative area many anesthesia care provider make promises to the child of “blowing up balloons” in the operating room. However, during routine mask induction, the anesthesia care provider will place the child on an operating room table in the supine position (on their back), then place a mask over the child's face. The mask is connected to a length of double corrugated tubing (a circuit) that extends back to the anesthesia machine. When the child inhales, a volatile anesthetic is inspired and puts the child to sleep. At the juncture between the corrugated tubing and the anesthesia machine, there is a reservoir bag that collects the expired gases and visibly inflates as the patient exhales. Unfortunately, pediatric patients of an age to be aware of the device often cannot see the reservoir bag due to their position on the table and the fact that they are unable to focus on anything other than the unpleasant smell of the anesthesia gas and the strangers forcibly holding them in place on the OR table.
Anesthesiologists typically use a mask for induction. One reason is that children are traumatized by needles and injections. Another reason is for a desire to capture the exhaled anesthetic so that others in the room are not affected by escaping anesthesia.
Many children experience varying levels of fear and associated trauma by the use of forceful restraint on an operating room table by strange adults while a “stinky” mask is shoved onto their face. For many children, this produces a feeling of suffocation; even a child who has been cooperative up until that point may begin to fight and cry while their parent, who has accompanied them back to the operating room, looks on in horror. Such a combination of effects is not conducive to a pleasant induction experience for the child in the first event and increasingly so if the child should require a series of operations or treatments. One test documenting fear and anxiety is found in the article by Gomez et al., “Efficacy of Anesthetic Premedication in Pediatric Patients Using Oral Midazolam and Acetaminophen. Observational Study”, Rev. Colomb. Anesthesiol., vol. 41, No. 1, pp. 4-9 (2013). Postoperative behavioral changes related to stressful hospital experiences/induction of anesthesia include general anxiety, enuresis, night-time crying, and temper tantrums. These changes are usually transient but may persist for up to 1 yr. See Tan et al., Anaesthesia for the Uncooperative Child”, Continuing Education in Anaesthesia, Critical Care & Pain, Vol. 10, No. 2, pp. 48-52 (2010).
A study reported by Kain et al. in “Distress During the Induction of Anesthesia and Postoperative Behavioral Outcomes”, Anesthesia & Analgesia, vol. 88, issue 5, pp. 1042-1047 (1999) found a correlation between anxiety during induction of anesthesia and negative postoperative behavioral changes:                The frequency of negative postoperative behavioral changes decreased with time after surgery, and the frequency of negative postoperative behavioral changes increased when the child exhibited increased anxiety during the induction of anesthesia. Finally, we found a significant correlation (r) of 0.42 (P=0.004) between the anxiety of the child during induction and the excitement score on arrival to the postanesthesia care unit. We conclude that children who are anxious during the induction of anesthesia have an increased likelihood of developing postoperative negative behavioral changes. We recommend that anesthesiologists advise parents of children who are anxious during the induction of anesthesia of the increased likelihood that their children will develop postoperative negative behavioral changes such as nightmares, separation anxiety, and aggression toward authority.        
The use of physical restraint of various degrees remains the recommended procedure for inducing anesthesia in the pediatric patient. See Tan et al., Anaesthesia for the Uncooperative Child”, Continuing Education in Anaesthesia, Critical Care & Pain, Vol. 10, No. 2, pp. 48-52 (2010).
A number of potential solutions have been proposed to handle traumatic circumstances experienced by pediatric patients. For example, U.S. Pat. No. 4,896,666 teaches the use of a mask assembly for infants having a detachable pacifier. The pacifier is said to calm the infant without requiring an overly large mask. In one embodiment, the anesthetic gas is passed through an opening in the pacifier thereby reducing detection of the smells of the anesthetic gases. See also U.S. Pat. Nos. 6,776,157 and 8,671,934.
U.S. Pat. No. 5,697,363 teaches the use of a headpiece having headphone speakers and a chamber that can be positioned over the patient's nose for delivery of the anesthesia gas.
U.S. Pat. Nos. 5,865,172; 5,937,852 and 6,073,628 describe a masked induction system for pediatric patients with a rotatable impeller disposed in the attached tubing and connected to a “sensory patient stimulator” that interacts with inspiratory or expiratory flow of gas through the conduit. Also disclosed are embodiments that involve a thermal paint that changes the color of the stimulator and an inflatable stimulator.
U.S. Pat. No. 6,463,928 is also a mask-based system that is designed for use with pediatric patients. The induction tubing incorporates toy-like devices, such as whistles and balloons that are said to be activated by deep breathing while also capturing the exhaled anesthesia gases.
A history of attempts at various distraction techniques during pediatric induction of anesthesia can also be found in the article by Litman, “Allaying Anxiety in Children—When a Funny Thing Happens on the Way to the Operating Room”, Anesthesiology, v. 115, no. 1, pp. 4-5 (2011).
The main problem with the prior art systems that rely on a mask is the mask itself. Placing the mask on the pediatric patient is an act that is confining, obstructs vision when the child most needs a wide field of view as adrenalin surges, feels confining and strange and suffocating, and introduces unpleasant smells. It is no wonder that the child reacts against such stimuli. One set of instructions to parents has this information for parents: “When going to sleep with a mask, children frequently try to take off the mask and/or become combative as they go to sleep. This is a normal reaction.” and “Children often will cough, gag, cry, complain about the smell or say they cannot breathe. These reactions are common responses to placing a mask over a child's mouth and nose.”
Parents, too, are affected by the reaction of their child to such mask-based pediatric induction techniques. See Zuwala et al., “Reducing Anxiety in Parents Before and During Pediatric Anesthesia Induction”, AANA Journal, vol. 69, no. 1, pp. 21-25 (2001) and Kain et al., “Parental Presence during Induction of Anesthesia—Physiological Effects on Parents”, Anesthesiology, vol. 98, no. 1, pp. 58-64 (2003). Traumatized parents may now feel inclined to voice their feelings about their induction experience in the post-procedure Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
The intent of the HCAHPS initiative is to provide a standardized survey instrument and data collection methodology for measuring patients' perspectives on hospital care. While many hospitals have collected information on patient satisfaction, prior to HCAHPS there was no national standard for collecting or publicly reporting patients' perspectives of care information that would enable valid comparisons to be made across all hospitals. In order to make “apples to apples” comparisons to support consumer choice, it was necessary to introduce a standard measurement approach. The result is the HCAHPS survey, which is also known as the CAHPS® Hospital Survey. (CAHPS is a federally registered trademark owned by the Agency for Healthcare Research and Quality in Rockville, Md.) HCAHPS is a core set of questions that can be combined with a broader, customized set of hospital-specific items. HCAHPS survey items complement the data hospitals currently collect to support improvements in internal customer services and quality related activities.
Three broad goals have shaped the HCAHPS survey. First, the survey is designed to produce comparable data on the patient's perspective on care that allows objective and meaningful comparisons between hospitals on domains that are important to consumers. Second, public reporting of the survey results is designed to create incentives for hospitals to improve their quality of care. Third, public reporting will serve to enhance public accountability in health care by increasing the transparency of the quality of hospital care provided in return for the public investment. With these goals in mind, the HCAHPS project has taken substantial steps to assure that the survey is credible, useful, and practical. This methodology and the information it generates are available to the public.
In May 2005, the National Quality Forum (NQF), an organization established to standardize health care quality measurement and reporting, formally endorsed the CAHPS® Hospital Survey. The NQF endorsement represents the consensus of many health care providers, consumer groups, professional associations, purchasers, federal agencies, and research and quality organizations. (Citation: http://goo.gl/mTs2g.)
With the development and acceptance of the HCAHPS survey, it will not be long before insurance companies start to use the HCAHPS scoring as a quality metrics tool for their reimbursement payments to hospitals. The federal department for Health and Human Services has already announced a pilot program to determine whether to include HCAHPS as part of its core set of quality measurements for children's health care. Parents who feel that their patient child has been traumatized or unnecessarily frightened by the techniques for pediatric induction of anesthesia may use their responses to the HCAHPS survey to voice their own trauma and distress to the detriment of the hospital.
It would be desirable to have a system and method for its use when inducing anesthesia in pediatric patients that would be free of the need to place a mask over the nose and mouth of pediatric patients and avoid the emotional reactions associated therewith by the patient as well as caregivers, parents and hospital staff.
It would also be desirable to have a system and method for its use that would provide distractions and/or fun activities for pediatric patients as anesthesia is induced.